Extension Study of XLHED-Affected Male Subjects Treated With EDI200 in Protocol ECP-002
Launched by EDIMER PHARMACEUTICALS · Nov 18, 2013
Trial Information
Current as of June 05, 2025
Unknown status
Keywords
ClinConnect Summary
X-linked hypohidrotic ectodermal dysplasia (XLHED) is a disorder of ectoderm development in which sweat and other secretory gland hypoplasias predispose affected infants to serious and potentially life-threatening hyperthermia and pneumonia. Those XLHED patients who survive infancy face a host of ectoderm-related clinical conditions including failure to thrive, oligodontia and misshapen teeth, mid-face hypoplasia, eczema, chronic dry eyes, asthma, respiratory infections, sinusitis and chronic nosebleeds. XLHED is caused by inherited defects in the ectodysplasin gene (EDA, www.ncbi.nlm.nih.g...
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- Subjects must meet all of the following criteria to be enrolled:
- • 1. Subject received at least one dose of EDI200 in the neonate study ECP-002
- • 2. Written informed consent of parent(s)
- Exclusion Criteria:
- Subjects who meet any of the following criteria may not be enrolled in this study:
- • 1. Medically-significant postnatal complications or congenital anomalies outside of those considered to be associated with the diagnosis of XLHED
- • 2. Major protocol violations during enrollment in study ECP-002 as determined by the Sponsor
About Edimer Pharmaceuticals
Edimer Pharmaceuticals is a biotechnology company focused on developing innovative therapies for rare genetic diseases, particularly those caused by protein deficiencies. With a commitment to addressing unmet medical needs, Edimer leverages advanced research and development techniques to create targeted treatments that enhance patient outcomes. The company's expertise lies in the identification and development of novel biologics, with an emphasis on rigorous clinical trials to ensure safety and efficacy. Edimer's mission is to transform the lives of patients and their families by bringing promising therapies from the lab to the clinic.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
San Francisco, California, United States
Saint Louis, Missouri, United States
Cardiff, , United Kingdom
Washington, D.C., District Of Columbia, United States
Paris, , France
Milan, , Italy
Erlangen, Bavaria, Germany
Patients applied
Trial Officials
Kenneth Huttner, MD, PhD
Study Director
Edimer Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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